More than 30 popular supplement ingredients left off India's new approved list

Supplement and functional food manufacturers have around two weeks to submit scientific data to get 34 ingredients currently used in products – including kale powder, plant-sourced vitamin D and kiwi extract – on India’s approved list.

New regulations came into force at the beginning of January, which obliged manufacturers to ensure compliance of their existing and new products.

A total of 195 ingredients have been added to the initial list first published by regulator FSSAI last year. These include resveratrol, lutein and beat-glucan.

However, 34 submitted ingredients have not yet been approved by the scientific panel due to “inadequate data”.​

The regulator stated: “[Companies] are given four weeks from the date of issuance of this direction [Dec 26] to submit the data required by the scientific panel. Meanwhile, they are allowed to continue the business of existing products containing [the] ingredients until further notice.​

"Products containing these ingredients for which data is not submitted within four weeks from the date of issuance of this direction are to be immediately withdrawn.”​

Furthermore, FSSAI has ruled that products containing fluoride and potato protein isolate must be immediately withdrawn from the market due to “safety concerns”.​

Drug properties

Willow bark extract, pyrrol quinoline quinone and lemon bam have also been banned “since they exhibit properties of a drug”.​

The draft proposals​ were first issued at the end of 2016. They cover health supplements, nutraceuticals, food for special dietary use, food for special medical purposes, functional foods and novel foods.

You can read here​ how the proposals were initially warmly welcomed by industry, which believed they offered much needed clarity and fill a long-standing regulatory vacuum.

However, by the middle of last year, concerns started to be raised, especially around the permitted ingredients.

This led FSSAI to pledge that such fears would be taken into consideration.

Speaking at the Associated Chambers of Commerce & Industry (ASSOCHAM) of India’s National Symposium on Nutraceuticals, FSSAI CEO Pawan Agarwal said: “I am taking this opportunity to reassure the industry here that if there are concerns with the standards we have released, we are still open to changing those standards, making provisions to address the concerns that you have.”​

He added it was hoped the rules would put India on a similar regulatory level to leading nations, while also establishing a strong, science-based environment for the industry in the country.